Patient Safety 101
The official and accepted definitions within patient safety are determined by this organization
What is the International Conference of Harmonization (ICH) Guideline?
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with the treatment
What is an adverse event?
What is 94%?
A hypothesis, supported by evidence from one or more sources, suggesting a new or previously unrecognized adverse event that may be caused by a medicine
What is a safety signal?
The most used application for analyzing adverse event data
What is Excel?
The science and activities related to the detection, assessment, understanding, and prevention of adverse effects.
What is pharmacovigilance?
There are 4 major databases that collect post-marketing adverse events
What is the FDA (US), EudraVigilance (EMA), MHRA (UK), and Vigibase?
What is Cobert's Manual of Drug Safety and Pharmacovigilance?
What is 76% or 953 signals?
This healthcare provider tends to submit most reports of adverse events
What are pharmacists?
Doctors, pharmacists, patients, caregivers, investigators, etc. are all responsible for collecting and ____ when a reaction occurs.
What is reporting adverse events?
Death, life-threatening, hospitalization, persistent or significant disability/incapacity, or congenital anomaly/birth defect are all characteristics for this type of adverse event
What is a serious adverse event?
A standardized medical terminology, published by the International Council for Harmonization, used in particular for coding cases of adverse effects in clinical study reports and pharmacovigilance databases, and to facilitate searches in these databases
What is MedDRA - Medical Dictionary for Regulatory Activities?
The FDA receives over ____ spontaneous reports of adverse events each year through its MedWatch program, which are the raw data for signal detection
What is 18,000?
A drug safety program required by the U.S. FDA for certain medications to ensure their benefits outweigh the risks by providing risk management and communication strategies to patients and healthcare providers
What is REMS or Risk Evaluation and Mitigation Strategies?
A case containing an identifiable patient, an identifiable reporter, a suspect product, and an adverse event or fatal outcome
What is a valid Individual Case Safety Report (ICSR)?
A regulatory document for authorized medical products that provides a comprehensive assessment of the product's benefit-risk profile, including all available safety data, since its authorization
What is a Periodic Safety Update Report (PSUR)?
A signal becomes this ___ when there is sufficient evidence to prove a reasonable causal association between the drug and event
What is a risk?
There are a variety of adverse events that are reported from clinical trials or post-marketing sources that may not necessarily be related to drug. True or false?
A detailed report of an adverse drug reaction or other safety information related to a medicine, collected from various sources like healthcare professionals or patients
What is an Individual Case Safety Report (ICSR)?
What is causality?
Our GPS Team at Alexion is made up of ___ members spread across Boston and Barcelona
What is 30+ members?
A mandatory document for medicinal products, submitted during the marketing authorization process, to characterize the product's safety profile, identify important risks, and detail planned actions to prevent or minimize these risks to maintain a positive benefit-risk balance
World Patient Safety Day is celebrated on this day every year (since 2019)
What is September 17th?